Protocols, Standing Orders, Order Sets, and Preprinted Orders

Protocols, Standing Orders, Order Sets, and Preprinted Orders: Cracking the Code to the CMS Hospital CoP and TJC Requirements

Are you aware of the requirements on standing orders promulgated by CMS that all hospitals must follow? This will also cover the Joint Commission standards on standing orders and protocols. Did you know there is four separate CMS hospital condition of participation sections that hospitals must be aware of? This program will cover the interpretive guidelines and regulations required by the Center for Medicare and Medicaid Services (CMS) related to Order Sets, Protocols, Preprinted Orders, and Standing Orders.

This has been a very confusing area for hospitals and this program will demystify the requirements. Any hospital that accepts Medicare or Medicaid patients must be in compliance with these standards and for all patients. This area has generated a large number of questions.

CMS created a tag number to house the major section regarding standing order requirements in the medical record chapter under Tag 457. There are a total of four separate sections in the hospital CoP manual that regulate this issue. This has been confusing for hospitals because two of the sections did not link to the other requirements in the CMS manual. CMS also moved most of the standing order requirements from tag 405 into the new section on tag 457. Standing orders must address well-defined clinical scenarios. Standing orders related to medications must be approved by the Medical staff and nursing and pharmacy leadership. There are many required radiology protocols and policies and these will be discussed.

The development of protocols and standing orders is best described as a journey. This program will provide the history of each of the four sections and what each section requires hospitals to do. This program will clarify this confusing area and make the requirements understandable for hospitals. This is especially important as hospitals move toward a complete electronic medical record. It is important that any order in the electronic medical record populate the entire order in the order section.

• Recall that hospitals must comply with the CMS CoP requirements if they accept Medicare or Medicaid reimbursement
• Discuss that CMS has requirements for standing orders and protocols in four separate sections
• Describe that all protocols must be approved by the Medical Staff even if the protocols are department specific
• Recall that the physician must sign off the standing order along with a date and time

Introduction

• What are the CoPs
• How to locate a copy of the CoP
• Survey and Certification website for changes
• Definitions
• Joint Commission standards on standing orders
• Examples
• CMS required radiology protocols

History

• History and development
• Tag 450 Changes
• A new tag number 457 was created
• final interpretive guidelines

Tag 457

• Use of pre-printed and electronic standing orders, order sets, and protocols for patient orders and what criteria are met
  • Medical staff approval
  • Orders based on national guidelines and evidence-based practice
• New tag number created under tag 457
• Tag 405 content moved to 457
• Orders and protocols review and approved by the medical staff
• Review by hospital’s nursing and pharmacy leadership
• Consistency with nationally recognized and evidence-based guidelines
• Periodic and regular review of orders and protocols by the Medical Staff and the hospital’s nursing and pharmacy leadership to determine the continuing usefulness and safety of the orders and protocols
• Dates, times, and authenticated  in the medical record by the ordering physician or another physician who is responsible for the care of the patient
• The person signing off the order must be acting according to their scope of practice and by state law

Tag 405

• Most of the sections moved to tag 457
• Order needed for all drugs and biologicals

Tag 406

• Drugs and biologicals prepared on the orders contained in standing orders, protocols, and electronic standing orders
• Vaccines may be administered per physician-approved hospital policy after an assessment of the contraindications (MEC must approve the protocol)
• Orders for drugs and biologicals requirements
• Order for vaccine must later be signed by the physician
• An exception to having the order signed off (dated and timed) is flu and Pneumovax
• Need to have an order for all drugs and biologicals
• Scope of practice issue

CMS Memo on Standing Orders in Hospitals

• Documenting as an order in the patient’s chart
• Requirements for signing off an order
• Requirements for a  written set of orders, or is using a preprinted order set
• Physician or practitioner must identify the total number of pages
• documenting additions to preprinted orders, strikeouts, or deletions
• electronic signature requirements for electronic orders
• State law and scope of practice  requirements
• Protocols used to standardize and optimize patient care by clinical guidelines or standards of practice
• Implementation of evidence-based protocols or order sets to be used with patients diagnosed with MI, CHF, pneumonia, or who are undergoing certain surgical procedures
• Formal protocols with code team or rapid response teams
• Pre-printed orders requirements
• All orders must be signed off, dated, and timed

Tag 450

• All entries in the medical record must be legible and complete
• Every entry must be signed, dated, and TIMED
• The last page of the order sheet must identify the total number of pages, be dated, timed, and signed off or authenticated
• The practitioner must initial every deletion, addition, strikeout to preprinted orders
• The same principles apply to electronic order sets as far as signed, dated, and time

Anyone involved in ensuring compliance with the CMS Hospital Conditions of Participation related to standing orders, protocols, order sets including the CEO, Chief Operating Officer, Chief Nursing Officer, Chief Risk Officer, Chief Medical Officer, Risk Management, Hospital legal counsel, Senior Leadership, Radiology Director, PI staff, Compliance Officer, Regulatory Officer, Joint Commission liaison, Pharmacy Director, Nurse Educator, Pharmacist, Rehab and Respiratory Director and staff, Patient Safety Officer, MEC committee members, Infection Preventionist, OR Manager, Anesthesia Director, Anesthesiologist, Staff Nurses, Nurse Managers, Nurse Supervisors, IS Department staff, Policy and Procedure Committee Members, and anyone involved in standing orders, protocols, order sets, and preprinted orders. This includes anyone who serves on a committee that reviews standing orders, order sets, and protocols.